updates to the alberta drug benefit list · for coverage, this drug must be initiated by a...

Updates to the Alberta Drug Benefit List

Effective December 12, 2019

ABC 40211/81160 (R2019/12)

Inquiries should be directed to:

Pharmacy Services Alberta Blue Cross 10009 108 Street NW Edmonton AB T5J 3C5

Telephone Number: (780) 498-8370 (Edmonton) (403) 294-4041 (Calgary) 1-800-361-9632 (Toll Free)

FAX Number: (780) 498-8406 1-877-305-9911 (Toll Free)

109BWebsite: https://www.alberta.ca/drug-benefit-list-and-drug-review-process.aspx

Administered by Alberta Blue Cross on behalf of Alberta Health.

The Drug Benefit List (DBL) is a list of drugs for which coverage may be provided to program participants. The DBL is not intended to be, and must not be used as a diagnostic or prescribing tool. Inclusion of a drug on the DBL does not mean or imply that the drug is fit or effective for any specific purpose. Prescribing professionals must always use their professional judgment and should refer to product monographs and any applicable practice guidelines when prescribing drugs. The product monograph contains information that may be required for the safe and effective use of the product.

Copies of the Alberta Drug Benefit List are available from Pharmacy Services, Alberta Blue Cross at the address shown above.

Binder and contents: $42.00 ($40.00 + $2.00 G.S.T.) Contents only: $36.75 ($35.00 + $1.75 G.S.T.)

A cheque or money order must accompany the request for copies.

https://www.alberta.ca/drug-benefit-list-and-drug-review-process.aspx

UPDATES TO THE ALBERTA DRUG BENEFIT LIST

EFFECTIVE DECEMBER 12, 2019

Table of Contents Drug Product(s) with Changes to Criteria for Coverage ............................................................................ 1

Biosimilar Initiative Transitioning Policy Drug Product(s) .......................................................................... 1

Part 3 Special Authorization .................................................................................................................... 3-1


EFFECTIVE DECEMBER 12, 2019 1

Drug Product(s) with Changes to Criteria for Coverage Trade Name / Strength / Form Generic Description DIN MFR

ENBREL 25 MG / VIAL INJECTION ETANERCEPT 00002242903 AMG

ENBREL 50 MG / SYRINGE INJECTION ETANERCEPT 00002274728 AMG

HUMIRA 40 MG / 0.8 ML SYRINGE INJECTION ADALIMUMAB 00002258595 ABV

RITUXAN 10 MG / ML INJECTION RITUXIMAB 00002241927 HLR

STELARA (0.5 ML VIAL OR SYRINGE) 45 MG INJECTION VIAL OR SYRINGE

USTEKINUMAB 00002320673 JAI

STELARA 90 MG / SYRINGE INJECTION USTEKINUMAB 00002320681 JAI

Biosimilar Initiative Transitioning Policy Drug Product(s) The following products are originator drug products for which there is a biosimilar or subsequent entry non-biologic complex drug treatment option for certain indications. As of July 1, 2020 claims for originator drug products for the specified indications will no longer be eligible.

Patients with an existing Special Authorization approval for a originator drug product for a specified indications will not require a new request to transition to the biosimilar or subsequent entry non-biologic complex drug product. Special Authorization approvals that are currently in place for the originator drug product will also be valid for the corresponding a biosimilar or subsequent entry non-biologic complex drug product until the Special Authorization renewal date.

Patients currently using a originator drug product for the specified indication will be granted a transition period until July 1, 2020. This transition period provides patients with the opportunity to discuss appropriate use with their health care provider and time to adjust to the biosimilar or subsequent entry non-biologic complex drug product, if needed.

Trade Name / Strength / Form Generic Description DIN MFR Indication(s)

COPAXONE 20 MG / SYRINGE INJECTION

GLATIRAMER ACETATE 00002245619 TMP MULTIPLE SCLEROSIS

ENBREL 25 MG / VIAL INJECTION ETANERCEPT 00002242903 AMG ANKYLOSING SPONDYLITIS PSORIATIC ARTHRITIS RHEUMATOID ARTHRITIS

ENBREL 50 MG / SYRINGE INJECTION

ETANERCEPT 00002274728 AMG ANKYLOSING SPONDYLITIS PSORIATIC ARTHRITIS RHEUMATOID ARTHRITIS

LANTUS 100 UNIT / ML INJECTION INSULIN GLARGINE 00002245689 SAV TYPE 1 DIABETES TYPE 2 DIABETES

LANTUS CARTRIDGE 100 UNIT / ML INJECTION

INSULIN GLARGINE 00002251930 SAV TYPE 1 DIABETES TYPE 2 DIABETES

LANTUS PEN 100 UNIT / ML INJECTION

INSULIN GLARGINE 00002294338 SAV TYPE 1 DIABETES TYPE 2 DIABETES

NEUPOGEN 0.3 MG / ML INJECTION FILGRASTIM 00001968017 AMG NEUTROPENIA


2 EFFECTIVE DECEMBER 12, 2019

Biosimilar Initiative Transitioning Policy Drug Product(s), continued

Trade Name / Strength / Form Generic Description DIN MFR Indication(s)

NEULASTA (0.6 ML) 6 MG / SYRINGE INJECTION

PEGFILGRASTIM 00002249790 AMG NEUTROPENIA

REMICADE 100 MG / VIAL INJECTION

INFLIXIMAB 00002244016 JAI ANKYLOSING SPONDYLITIS PLAQUE PSORIASIS PSORIATIC ARTHRITIS RHEUMATOID ARTHRITIS CROHN'S DISEASE ULCERATIVE COLITIS

Special Authorization

PART 3

Special Authorization

CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS ALBERTA DRUG BENEFIT LIST UPDATE

ADALIMUMAB

1 EFFECTIVE DECEMBER 12, 2019UNIT OF ISSUE - REFER TO PRICE POLICY .3

Ankylosing Spondylitis

"Special authorization coverage may be provided for the reduction in the signs and symptoms ofseverely active Ankylosing Spondylitis, as defined by the Modified New York criteria for Ankylosing Spondylitis, in adult patients (18 years of age or older) who have active disease as demonstrated by:

- a BASDAI greater than or equal to 4 units, demonstrated on 2 occasions at least 8 weeks apartAND- a Spinal Pain VAS of greater than or equal to 4 cm (on a 0-10 cm scale), demonstrated on 2 occasions at least 8 weeks apart AND- who are refractory or intolerant to:

at least TWO of the following- Brenzys (etanercept)- Cimzia (certolizumab pegol)- Cosentyx (secukinumab)- Erelzi (etanercept)- Inflectra (infliximab)- Renflexis (infliximab)- Simponi (golimumab)

AND

- treatment with 2 or more NSAIDS each taken for a minimum of 4 weeks at maximum tolerated or recommended doses.

'Refractory' is defined as lack of effect at the recommended doses and for duration of treatmentsspecified above.'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in product monographs.

For coverage, this drug must be initiated by a Specialist in Rheumatology ("RA Specialist").

- Initial coverage may be approved for 12 weeks as follows: An initial 40 mg dose, followed by additional 40 mg doses administered every two weeks for up to 12 weeks after the first dose.- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond 12 weeks, the patient must meet the following criteria:1) The patient must be assessed at 12 weeks by an RA Specialist after the initial 12 weeks of therapy to determine response.2) The RA Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:- Reduction of the BASDAI score by at least 50% of the pre-treatment value or by 2 or more units, AND- Reduction of the Spinal Pain VAS by 2 cm or more.

Following this assessment, continued coverage may be approved for one 40 mg dose every other week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by an RA Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."

The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.


PRODUCT IS NOT INTERCHANGEABLE

ADALIMUMAB

2 EFFECTIVE DECEMBER 12, 2019 .3

All requests (including renewal requests) for adalimumab for Ankylosing Spondylitis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form (ABC 60028).

Hidradenitis Suppurativa

"Special authorization may be provided for the treatment of adult patients with active moderate to severe Hidradenitis Suppurativa who meet all of the following criteria:

- A total abscess and nodule (AN) count of 3 or greater.- Lesions in at least two distinct anatomical areas, one of which must be Hurley Stage II or III.- An inadequate response to a 90-day trial of systemic antibiotics AND documented non response to conventional therapy.For coverage, this drug must be initiated by a Specialist in Dermatology ("Dermatology Specialist").

- Initial coverage may be approved for 12 weeks as follows: an initial dose of 160 mg, followed by one 80 mg dose two weeks later, then 40 mg every week beginning four weeks after the initial dose, for a total of eleven doses.- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond the initial approval period the patient must meet the following criteria:

1) The patient must be assessed by a Dermatology Specialist after 12 weeks of treatment to determine response.2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:

- Greater than or equal to 50% reduction in AN count from pre-treatment baseline AND- no increase in abscess count or draining fistula count relative to pre-treatment baseline.

Note: Treatment with adalimumab should be discontinued if there is insufficient improvement after 12 weeks of treatment.

Following this assessment, continued coverage may be considered for one 40 mg dose of adalimumab every week for an additional period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."

All requests (including renewal requests) for adalimumab for Hidradenitis Suppurativa must be completed using the Adalimumab for Hidradenitis Suppurativa Special Authorization Request Form (ABC 60058).

Moderately to Severe Active Crohn's Disease

"Special authorization coverage may be approved for coverage of adalimumab for the reduction in signs and symptoms and induction and maintenance of clinical remission of Moderately to Severely Active Crohn's Disease in patients who meet the following criteria:

- Adalimumab must be prescribed by a Specialist in Gastroenterology or a physician appropriately trained by the University of Alberta or the University of Calgary and recognized as a prescriber by Alberta Blue Cross for adalimumab for coverage for the treatment of Moderately to Severely Active Crohn's Disease patients ('Specialist').- Patients must be 18 years of age or older to be considered for coverage of adalimumab.- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.



ADALIMUMAB


- Patients may be allowed to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy (both primary loss of response and secondary loss of response) or due to serious adverse effects or contraindications. An adequatetrial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

Prior to initiation of adalimumab therapy for New Patients:

'New Patients' are patients who have never been treated with adalimumab by any health care provider.

Moderately to Severely Active Crohn's Disease:

Prior to initiation of adalimumab therapy, New Patients must have a current Modified (without the physical exam) Harvey Bradshaw Index score of greater than or equal to 7 (New Patient's Baseline Score), AND be Refractory.

Refractory is defined as one or more of the following:1) Serious adverse effects or reactions to the treatments specified below; OR2) Contraindications (as defined in product monographs) to the treatments specified below; OR3) Previous documented lack of effect at doses and for duration of all treatments specified below:a) mesalamine: minimum of 3 grams/day for a minimum of 6 weeks; AND refractory to, or dependent on, glucocorticoids: following at least one tapering dosing schedule of 40 mg/day, tapering by 5 mg each week to 20 mg, then tapering by 2.5 mg each week to zero, or similar.

[Note: Patients who have used the above treatments in combination will not be required to be challenged with individual treatments as monotherapy]

ANDb) Immunosuppressive therapy as follows:- Azathioprine: minimum of 2 mg/kg/day for a minimum of 3 months; OR- 6-mercaptopurine: minimum of 1 mg/kg/day for a minimum of 3 months; OR- Methotrexate: minimum or 15 mg/week for a minimum of 3 months.OR- Immunosuppressive therapy discontinued at less than 3 months due to serious adverse effectsor reactions;

AND

c) refractory or intolerant to at least TWO of the following:- Entyvio (vedolizumab)- Inflectra (infliximab)- Renflexis (infliximab).

Applications for coverage must include information regarding the dosages and duration of trial ofeach treatment the patient received, a description of any adverse effects, reactions, contraindications and/or lack of effect, as well as any other information requested by Alberta Blue Cross.

Coverage Criteria for Moderately to Severely Active Crohn's Disease

- New Patients must meet the criteria above prior to being considered for approval.- All approvals are also subject to the following applicable criteria.

Induction Dosing for New Patients:




ADALIMUMAB


- Coverage for Induction Dosing may only be approved for New Patients (those who have never been treated with adalimumab by any health care provider).- 'Induction Dosing' means a maximum of one 160 mg dose of adalimumab per New Patient at week 0 followed by an 80 mg dose at week 2.- New Patients are eligible to receive Induction Dosing only once, after which time the Maintenance Dosing for New Patients and Continued Coverage for Maintenance Dosing criteria will apply.- As an interim measure, 40 mg doses of adalimumab will be provided at weeks 4, 6, 8 and 10 toallow time to determine whether the New Patient meets coverage criteria for Maintenance Dosing below.

Maintenance Dosing:

'Maintenance Dosing' means one 40 mg dose of adalimumab per patient provided no more often than every other week starting at week 4 for a period of 12 months to:- New Patients following the completion of Induction Dosing; OR- Existing Patients, who are patients that are being treated, or have previously been treated, withadalimumab.

Maintenance Dosing for New Patients after Completion of Induction Dosing:

- The New Patient must be assessed by a Specialist within 12 weeks after the initiation of Induction Dosing to determine response by obtaining a Modified Harvey Bradshaw Index score for patients with Moderately to Severely Active Crohn's Disease; AND- The Specialist must confirm the Modified Harvey Bradshaw Index score shows a decrease from the New Patient's Baseline Score of greater than or equal to 3 points for patients with Moderately to Severely Active Crohn's.

Maintenance Dosing for Existing Patients:

- The patient must be assessed by a Specialist annually (within 2 months of the expiry of a patient's special authorization) at least 2 weeks after the day a dose of adalimumab was administered to the patient and prior to administration of the next dose to obtain: a Modified Harvey Bradshaw Index Score (Existing Patient's Baseline Score) for Moderately to Severely Active Crohn's Disease; AND- these measures must be provided to Alberta Blue Cross for assessment for continued coverage for maintenance dosing.

Continued Coverage for Maintenance Dosing:

Continued coverage may be considered for one 40 mg dose of adalimumab per patient providedno more often than every other week for a period of 12 months, if the following criteria are met atthe end of each 12 month period:

- The New Patient or the Existing Patient must be assessed by a Specialist annually (within 2 months of the expiry of a patient's special authorization) at least 2 weeks after the day a dose of adalimumab was administered to the patient and prior to administration of the next dose to obtain: a Modified Harvey Bradshaw Index Score for Moderately to Severely Active Crohn's Disease; AND- For New Patients: The Specialist must confirm that the patient has maintained a greater than or equal to 3 point decrease from the New Patient's Baseline Score for Moderately to Severely Active Crohn's; OR- For Existing Patients: The Specialist must confirm that the patient has maintained the Existing Patient's Baseline Score."

All requests (including renewal requests) for adalimumab for Moderately to Severely Active Crohn's Disease must be completed using the Adalimumab/Vedolizumab for Crohn's/Infliximab for Crohn's/Fistulizing Crohn's Special Authorization Request Form (ABC 60031).

Plaque Psoriasis



ADALIMUMAB


"Special authorization coverage may be provided for the reduction in signs and symptoms of severe, debilitating psoriasis in patients who:- Have a total PASI of 10 or more and a DLQI of more than 10, OR- Who have significant involvement of the face, palms of the hands, soles of the feet or genital region; AND- Who are refractory or intolerant to:

at least TWO of the following:- Cosentyx (secukinumab)- Inflectra (infliximab)- Renflexis (infliximab)- Taltz (ixekizumab);

AND

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory, OR- Cyclosporine (6 weeks treatment); AND- Phototherapy (unless restricted by geographic location)Patients who have a contraindication to either cyclosporine or methotrexate will be required to complete an adequate trial of the other pre-requisite medication prior to potential coverage beingconsidered.


For coverage, this drug must be prescribed by a Specialist in Dermatology ("Dermatology Specialist").

- Initial coverage may be approved for an initial dose of 80 mg, followed by one 40 mg dose every other week beginning one week after the first dose, for a total of nine doses.- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond nine doses, the patient must meet all of the following criteria:1) The patient must be assessed by a Dermatology Specialist after the initial nine doses to determine response.2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:- Greater than or equal to 75% reduction in PASI score, OR- Greater than or equal to 50% reduction in PASI score AND improvement of greater than or equal to 5 points in the DLQI.

Following this assessment, continued coverage may be considered for one 40 mg dose of adalimumab every other week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology Specialist every 12 months and is confirmed to becontinuing to respond to therapy by meeting criteria as outlined in (2) above."




ADALIMUMAB


PASI and DLQI scores are required for all requests for Plaque Psoriasis including those requests for patients that have significant involvement of the face, palms, soles of feet or genital region.

All requests (including renewal requests) for adalimumab for Plaque Psoriasis must be completed using the Adalimumab/Etanercept/Infliximab/Ixekizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030).

Polyarticular Juvenile Idiopathic Arthritis

"Special authorization coverage may be provided for the reduction in signs and symptoms of severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 4 years of age and older who:- Have 5 or more active joints (defined by either swelling or limitation of motion plus pain and/or tenderness), AND- Are refractory to one or more disease modifying anti-rheumatic agents (DMARDS) conventionally used in children (minimum three month trial).

"Refractory" is defined as one or more of the following: lack of effect, serious adverse effects (e.g., leukopenia, hepatitis) or contraindications to treatments as defined in the product monographs.

For coverage, this drug must be prescribed by a prescriber affiliated with a Pediatric Rheumatology Clinic in Edmonton or Calgary (Pediatric Rheumatology Specialist).

- Coverage may be approved for 24 mg per square meter body surface area (maximum dose 40mg) every other week for 12 weeks.- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of abatacept) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimumthe completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from abatacept to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage of this agent beyond 12 weeks, the patient must meet the following criteria:1) The patient must be assessed by a Pediatric Rheumatology Specialist after 12 weeks, but no longer than 16 weeks after, treatment with this biologic agent to determine response.2) The Pediatric Rheumatology Specialist must confirm in writing that the patient is a responder that meets the following criteria (ACR Pedi 30):- 30% improvement from baseline in at least three of the following six response variables, with worsening of 30% or more in no more than one of the six variables. The variables include:i. global assessment of the severity of the disease by the Pediatric Rheumatology Specialist,ii. global assessment of overall well-being by the patient or parent,iii. number of active joints (joints with swelling not due to deformity or joints with limitation of motion with pain tenderness or both),iv. number of joints with limitation of motion,v. functional ability based on CHAQ scores,vi. ESR or CRP3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request.

Following this assessment, continued coverage may be approved for 24 mg per square meter body surface area (maximum dose 40 mg) every other week, for a maximum of twelve months.



ADALIMUMAB


After twelve months, in order to be considered for continued coverage, the patient must be re-assessed every twelve months by a Pediatric Rheumatology Specialist and must meet the following criteria:1) The patient has been assessed by a Pediatric Rheumatology Specialist to determine response, and2) The Pediatric Rheumatology Specialist must confirm in writing that the patient has maintaineda response to therapy as indicated by maintenance of the ACR Pedi 30,3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request.

Once a child with pJIA has had two disease-free years, it is common clinical practice for drug treatment to be stopped."

All requests (including renewal requests) for adalimumab for Polyarticular Juvenile Idiopathic Arthritis must be completed using the Adalimumab/Etanercept/Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form (ABC 60011).

Psoriatic Arthritis

"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in adult patients (18 years of age or older) with moderate to severe polyarticular psoriaticarthritis (PsA) or pauciarticular PsA with involvement of knee or hip joint who are refractory or intolerant to:

at least TWO of the following:- Cimzia (certolizumab pegol)- Cosentyx (secukinumab)- Erelzi (etanercept)- Inflectra (infliximab)- Renflexis (infliximab)- Simponi (golimumab)- Taltz (ixekizumab)

AND

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinicalresponse to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4 month trial).

Special authorization coverage of this agent may be provided for use as monotherapy in adult patients for whom methotrexate is contraindicated and/or for those patients who have experienced serious adverse effects.



- Initial coverage may be approved for 40 mg administered every other week for 8 weeks.- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction




ADALIMUMAB


dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond 8 weeks, the patient must meet the following criteria:1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after, to determine response.2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the following criteria:- ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the correct number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for doses of 40 mg every other week, for a period of 12 months. Ongoing coverage may be considered if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the correct number of decimal places as indicated above."

All requests (including renewal requests) for adalimumab for Psoriatic Arthritis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form (ABC 60029).

Rheumatoid Arthritis

"Special authorization coverage may be provided for use in combination with methotrexate for the reduction in signs and symptoms of severely active Rheumatoid Arthritis (RA) in adult patients (18 years of age or older) who are refractory or intolerant to:

at least FOUR of the following:- Actemra (tocilizumab)- Brenzys (etanercept)- Cimzia (certolizumab pegol)- Erelzi (etanercept)- Inflectra (infliximab)- Kevzara (sarilumab)- Orencia (abatacept)- Renflexis (infliximab)- Simponi (golimumab)- Xeljanz (tofacitinib)

AND

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinicalresponse to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND



ADALIMUMAB


- Methotrexate with other disease modifying anti-rheumatic agent(s) (minimum 4 month trial) [e.g., methotrexate with hydroxychloroquine or methotrexate with sulfasalazine]; AND- Leflunomide (minimum 10 week trial at 20 mg daily)




- Initial coverage may be approved for five doses as follows: An initial 40 mg dose, followed by additional 40 mg doses at 2, 4, 6 and 8 weeks after the first dose.- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from anakinra to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond five doses, the patient must meet the following criteria:1) The patient must be assessed by an RA Specialist after the initial five doses to determine response.2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the following criteria:- ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the correct number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 40 mg every other week for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- confirmation of maintenance of ACR20, or- maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the correct number of decimal places as indicated above."

All requests (including renewal requests) for adalimumab for Rheumatoid Arthritis must be completed using the Abatacept/Adalimumab/Anakinra/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form (ABC 60027).




ADALIMUMAB


Ulcerative Colitis

"Special authorization coverage may be provided for the reduction in signs and symptoms and induction and maintenance of clinical remission of Ulcerative Colitis in adult patients (18 years ofage or older) with active disease (characterized by a partial Mayo score >4 prior to initiation of biologic therapy) and who are refractory or intolerant to:- mesalamine: minimum of 4 grams/day for a minimum of 4 weeks; AND- corticosteroids (failure to respond to prednisone 40 mg daily for 2 weeks, or; steroid dependenti.e. failure to taper off steroids without recurrence of disease or disease requiring a second dose of steroids within 12 months of previous dose).


Immunosuppressive therapy as follows may also be initiated if in the clinician's judgment a trial is warranted:i) Azathioprine: minimum of 2 mg/kg/day for a minimum of 2 months; ORii) 6-mercaptopurine: minimum of 1 mg/kg/day for a minimum of 2 months

For coverage, this drug must be prescribed by a Specialist in Gastroenterology or a physician appropriately trained by the University of Alberta or the University of Calgary and recognized as a prescriber by Alberta Blue Cross ('Specialist').

Initial coverage may be approved for an initial dose of 160 mg, followed by an 80 mg dose at week 2, then one 40 mg dose at weeks 4, 6 and 8. As an interim measure, an additional 40 mg dose of adalimumab will be provided at week 10 to allow time to determine whether the New Patient meets coverage criteria for Maintenance Dosing below, for a total of six doses.

- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond the initial coverage period, the patient must meet the following criteria:1) The patient must be assessed by a Specialist between weeks 8 and 12 after the initiation of therapy to determine response.2) The Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria:- a decrease in the partial Mayo score of greater than or equal to 2 points

Following this assessment, continued coverage may be approved for a dose of 40 mg every 2 weeks for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by a Specialist in Gastroenterology to determine response;2) The Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- a decrease in the partial Mayo score of greater than or equal to 2 points from the score prior to initiation of adalimumab therapy."

All requests (including renewal requests) for adalimumab for Ulcerative Colitis must be completed using the Adalimumab/Golimumab/Infliximab/Vedolizumab for Ulcerative Colitis



ADALIMUMAB

40 MG / SYR INJECTION SYRINGE

00002258595 HUMIRA (40 MG/0.8 ML INJ SYR) ABV 762.5700

11 EFFECTIVE DECEMBER 12, 2019UNIT OF ISSUE - REFER TO PRICE POLICY

$

.3

Special Authorization Request Form (ABC 60008).




ETANERCEPT25 MG / VIAL INJECTION

00002242903 ENBREL AMG 200.7100


$

.3 The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.


***Effective March 1, 2018, all new Special Authorization requests for the treatment of Rheumatoid Arthritis or Ankylosing Spondylitis for etanercept-naive patients will be assessed for coverage with Brenzys or Erelzi. Effective June 1, 2019, all new Special Authorization requests for the treatment of Psoriatic Arthritis for etanercept-naive patients will be assessed for coverage with Erelzi. Enbrel will not be approved for new etanercept starts for patients with the indications stated above; however, coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.

In addition, all new Special Authorization requests for the treatment of Polyarticular Juvenile Idiopathic Arthritis for etanercept-naive patients weighing 63 kg (138 pounds) or more will be assessed for coverage with Erelzi. Enbrel will be approved for new etanercept starts for pediatric patients with Polyarticular Juvenile Idiopathic Arthritis weighing less than 63 kg, and coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.

Additionally, patients will not be permitted to switch between etanercept products, if the patient has been previously trialed on any etanercept product and deemed unresponsive to therapy.***

"Special authorization coverage may be provided for the reduction in the signs and symptoms of severely active Ankylosing Spondylitis, as defined by the Modified New York criteria for Ankylosing Spondylitis, in adult patients (18 years of age or older) who have active disease as demonstrated by:

- a BASDAI greater than or equal to 4 units, demonstrated on 2 occasions at least 8 weeks apart AND

- a Spinal Pain VAS of greater than or equal to 4 cm (on a 0-10 cm scale), demonstrated on 2 occasions at least 8 weeks apart AND

- who are refractory or intolerant to treatment with 2 or more NSAIDS each taken for a minimum of 4 weeks at maximum tolerated or recommended doses.

'Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above.

'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments asdefined in product monographs.


- Initial coverage may be approved for 50 mg per week for 12 weeks.

- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.

- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).

- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.

- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage beyond 12 weeks, the patient must meet the following criteria:

1) The patient must be assessed at week 12 by an RA Specialist after the initial twelve weeks of therapy to determine response.


ETANERCEPT

13 EFFECTIVE DECEMBER 12, 2019UNIT OF ISSUE - REFER TO PRICE POLICY .3 The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

2) The RA Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:

- Reduction of the BASDAI score by at least 50% of the pre-treatment value or by 2 or more units, AND

- Reduction of the Spinal Pain VAS by 2 cm or more.

Following this assessment, continued coverage may be approved for 50 mg per week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by an RA Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."

All requests (including renewal requests) for etanercept for Ankylosing Spondylitis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form (ABC 60028).

Plaque Psoriasis




"Special authorization coverage may be provided for the reduction in signs and symptoms of severe, debilitating plaque psoriasis in patients who:

- Have a total PASI of 10 or more and a DLQI of more than 10, OR

- Who have significant involvement of the face, palms of the hands, soles of the feet or genital region; AND

- Who are refractory or intolerant to:

-at least TWO of the following:

- Cosentyx (secukinumab)- Inflectra (infliximab)- Renflexis (infliximab)- Taltz (ixekizumab);

AND

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory, OR

- Cyclosporine (6 weeks treatment); AND

- Phototherapy (unless restricted by geographic location)



ETANERCEPT

14 EFFECTIVE DECEMBER 12, 2019 .3 The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

Patients who have a contraindication to either cyclosporine or methotrexate will be required to complete an adequate trial of the other pre-requisite medication prior to potential coverage being considered.




- Initial coverage may be approved for up to 100 mg per week for 12 weeks.





For continued coverage beyond 12 weeks, the patient must meet all of the following criteria:

1) The patient must be assessed by a Dermatology Specialist after the initial 12 weeks of therapy todetermine response.

2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:

- Greater than or equal to 75% reduction in PASI score, OR

- Greater than or equal to 50% reduction in PASI score AND improvement of greater than or equal to 5 points in the DLQI

Following this assessment, continued coverage may be considered for 50 mg per week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."


All requests (including renewal requests) for etanercept for Plaque Psoriasis must be completed using the Adalimumab/Etanercept/Infliximab/Ixekizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030).



In addition, all new Special Authorization requests for the treatment of Polyarticular Juvenile Idiopathic Arthritis for etanercept-naive patients weighing 63 kg (138 pounds) or more will be


ETANERCEPT


assessed for coverage with Erelzi. Enbrel will be approved for new etanercept starts for pediatric patients with Polyarticular Juvenile Idiopathic Arthritis weighing less than 63 kg, and coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.





- Coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly for 12 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of abatacept) following an adequate trial of the first biologic agent if unresponsive to therapy, or due toserious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from abatacept to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage of this agent beyond 12 weeks, the patient must meet the following criteria:1) The patient must be assessed by a Pediatric Rheumatology Specialist after 12 weeks, but no longer than 16 weeks after, treatment with this biologic agent to determine response.2) The Pediatric Rheumatology Specialist must confirm in writing that the patient is a responder thatmeets the following criteria (ACR Pedi 30):- 30% improvement from baseline in at least three of the following six response variables, with worsening of 30% or more in no more than one of the six variables. The variables include:i. global assessment of the severity of the disease by the Pediatric Rheumatology Specialist,ii. global assessment of overall well-being by the patient or parent,iii. number of active joints (joints with swelling not due to deformity or joints with limitation of motion with pain tenderness or both),iv. number of joints with limitation of motion,v. functional ability based on CHAQ scores,vi. ESR or CRP3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request

Following this assessment, continued coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly, for a maximum of twelve months. After twelve months, in order to be considered for continued coverage, the patient must be re-assessed every twelve months by a Pediatric Rheumatology Specialist and must meet the following criteria:1) The patient has been assessed by a Pediatric Rheumatology Specialist to determine response, and2) The Pediatric RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by maintenance of the ACR Pedi 30,3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request.




ETANERCEPT


All requests (including renewal requests) for etanercept for Polyarticular Juvenile Idiopathic Arthritis must be completed using the Adalimumab/Etanercept/Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form (ABC 60011).

Psoriatic Arthritis




"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in adult patients (18 years of age or older) with moderate to severe polyarticular psoriatic arthritis (PsA) or pauciarticular PsA with involvement of knee or hip joint who are refractory or intolerant to:- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4 month trial).


'Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above.'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments asdefined in product monographs.


- Initial coverage may be approved for 50 mg per week for 8 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy. - Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage beyond 8 weeks, the patient must meet the following criteria: 1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response. 2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria: - ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the


ETANERCEPT


correct number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."

All requests (including renewal requests) for etanercept for Psoriatic Arthritis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form (ABC 60029).






- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND

- Methotrexate with other disease modifying anti-rheumatic agent(s) (minimum 4-month trial). [e.g., methotrexate with hydroxychloroquine or methotrexate with sulfasalazine]; AND

- Leflunomide (minimum 10 week trial at 20 mg daily).







ETANERCEPT




- Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).


- Patients will not be permitted to switch from anakinra to other biologic agents except under exceptional circumstances.



1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response.

2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria:

- ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND

- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].

It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period:

1) The patient has been assessed by an RA Specialist to determine response;

2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:

- Confirmation of maintenance of ACR20, or

- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.

3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."

All requests (including renewal requests) for etanercept for Rheumatoid Arthritis must be completedusing the Abatacept/Adalimumab/Anakinra/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form (ABC 60027).


ETANERCEPT50 MG / SYR INJECTION SYRINGE

00002274728 ENBREL AMG 401.5400


UNIT OF ISSUE - REFER TO PRICE POLICY

$

.3 The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.





"Special authorization coverage may be provided for the reduction in the signs and symptoms of severely active Ankylosing Spondylitis, as defined by the Modified New York criteria for Ankylosing Spondylitis, in adult patients (18 years of age or older) who have active disease as demonstrated by:

- a BASDAI greater than or equal to 4 units, demonstrated on 2 occasions at least 8 weeks apart AND

- a Spinal Pain VAS of greater than or equal to 4 cm (on a 0-10 cm scale), demonstrated on 2 occasions at least 8 weeks apart AND

- who are refractory or intolerant to treatment with 2 or more NSAIDS each taken for a minimum of 4 weeks at maximum tolerated or recommended doses.










1) The patient must be assessed at week 12 by an RA Specialist after the initial twelve weeks of therapy to determine response.



ETANERCEPT


2) The RA Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:

- Reduction of the BASDAI score by at least 50% of the pre-treatment value or by 2 or more units, AND

- Reduction of the Spinal Pain VAS by 2 cm or more.

Following this assessment, continued coverage may be approved for 50 mg per week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by an RA Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."

All requests (including renewal requests) for etanercept for Ankylosing Spondylitis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form (ABC 60028).

Plaque Psoriasis




"Special authorization coverage may be provided for the reduction in signs and symptoms of severe, debilitating plaque psoriasis in patients who:

- Have a total PASI of 10 or more and a DLQI of more than 10, OR

- Who have significant involvement of the face, palms of the hands, soles of the feet or genital region; AND

- Who are refractory or intolerant to:

-at least TWO of the following:

- Cosentyx (secukinumab)- Inflectra (infliximab)- Renflexis (infliximab)- Taltz (ixekizumab);

AND

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory, OR

- Cyclosporine (6 weeks treatment); AND

- Phototherapy (unless restricted by geographic location)


ETANERCEPT


Patients who have a contraindication to either cyclosporine or methotrexate will be required to complete an adequate trial of the other pre-requisite medication prior to potential coverage being considered.




- Initial coverage may be approved for up to 100 mg per week for 12 weeks.





For continued coverage beyond 12 weeks, the patient must meet all of the following criteria:

1) The patient must be assessed by a Dermatology Specialist after the initial 12 weeks of therapy todetermine response.

2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:

- Greater than or equal to 75% reduction in PASI score, OR

- Greater than or equal to 50% reduction in PASI score AND improvement of greater than or equal to 5 points in the DLQI

Following this assessment, continued coverage may be considered for 50 mg per week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."


All requests (including renewal requests) for etanercept for Plaque Psoriasis must be completed using the Adalimumab/Etanercept/Infliximab/Ixekizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030).



In addition, all new Special Authorization requests for the treatment of Polyarticular Juvenile Idiopathic Arthritis for etanercept-naive patients weighing 63 kg (138 pounds) or more will be



ETANERCEPT


assessed for coverage with Erelzi. Enbrel will be approved for new etanercept starts for pediatric patients with Polyarticular Juvenile Idiopathic Arthritis weighing less than 63 kg, and coverage for Enbrel will continue for patients who are currently well maintained on Enbrel and are considered a 'responder' as defined in criteria.





- Coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly for 12 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of abatacept) following an adequate trial of the first biologic agent if unresponsive to therapy, or due toserious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from abatacept to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage of this agent beyond 12 weeks, the patient must meet the following criteria:1) The patient must be assessed by a Pediatric Rheumatology Specialist after 12 weeks, but no longer than 16 weeks after, treatment with this biologic agent to determine response.2) The Pediatric Rheumatology Specialist must confirm in writing that the patient is a responder thatmeets the following criteria (ACR Pedi 30):- 30% improvement from baseline in at least three of the following six response variables, with worsening of 30% or more in no more than one of the six variables. The variables include:i. global assessment of the severity of the disease by the Pediatric Rheumatology Specialist,ii. global assessment of overall well-being by the patient or parent,iii. number of active joints (joints with swelling not due to deformity or joints with limitation of motion with pain tenderness or both),iv. number of joints with limitation of motion,v. functional ability based on CHAQ scores,vi. ESR or CRP3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request

Following this assessment, continued coverage may be approved for 0.8 mg/kg/dose (maximum dose 50 mg) weekly, for a maximum of twelve months. After twelve months, in order to be considered for continued coverage, the patient must be re-assessed every twelve months by a Pediatric Rheumatology Specialist and must meet the following criteria:1) The patient has been assessed by a Pediatric Rheumatology Specialist to determine response, and2) The Pediatric RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by maintenance of the ACR Pedi 30,3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request.



ETANERCEPT


All requests (including renewal requests) for etanercept for Polyarticular Juvenile Idiopathic Arthritis must be completed using the Adalimumab/Etanercept/Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form (ABC 60011).

Psoriatic Arthritis




"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in adult patients (18 years of age or older) with moderate to severe polyarticular psoriatic arthritis (PsA) or pauciarticular PsA with involvement of knee or hip joint who are refractory or intolerant to:- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4 month trial).


'Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above.'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments asdefined in product monographs.


- Initial coverage may be approved for 50 mg per week for 8 weeks.- Patients will be limited to receiving a one-month supply of etanercept per prescription at their pharmacy. - Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which itis being prescribed.

For continued coverage beyond 8 weeks, the patient must meet the following criteria: 1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response. 2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria: - ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the



ETANERCEPT


correct number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered if the following criteria are met at the end of each 12-month period:1) The patient has been assessed by an RA Specialist to determine response;2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:- Confirmation of maintenance of ACR20, or- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."

All requests (including renewal requests) for etanercept for Psoriatic Arthritis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form (ABC 60029).






- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND

- Methotrexate with other disease modifying anti-rheumatic agent(s) (minimum 4-month trial). [e.g., methotrexate with hydroxychloroquine or methotrexate with sulfasalazine]; AND

- Leflunomide (minimum 10 week trial at 20 mg daily).






ETANERCEPT




- Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).


- Patients will not be permitted to switch from anakinra to other biologic agents except under exceptional circumstances.



1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after treatment to determine response.

2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the followingcriteria:

- ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND

- An improvement of 0.22 in HAQ score [reported to two (2) decimal places].

It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above.

Following this assessment, continued coverage may be approved for 50 mg per week, for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period:

1) The patient has been assessed by an RA Specialist to determine response;

2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:

- Confirmation of maintenance of ACR20, or

- Maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline.

3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to thecorrect number of decimal places as indicated above."

All requests (including renewal requests) for etanercept for Rheumatoid Arthritis must be completedusing the Abatacept/Adalimumab/Anakinra/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form (ABC 60027).



RITUXIMAB


Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)

"For use in combination with glucocorticoids for the induction of remission of severely active granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) or microscopic polyangiitis (MPA) in adult patients who have:- Severe active disease that is life- or organ-threatening. The organ(s) and how the organ(s) is (are) threatened must be specified; AND- A positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic antibody) or myeloperoxidase-ANCA. A copy of the lab report must be provided; AND- Cyclophosphamide cannot be used for ONE of the following reasons:a) The patient has failed a minimum of six intravenous pulses of cyclophosphamide; ORb) The patient has failed three months of oral cyclophosphamide therapy; ORc) The patient has a severe intolerance or an allergy to cyclophosphamide; ORd) Cyclophosphamide is contraindicated; ORe) The patient has received a cumulative lifetime dose of at least 25 grams of cyclophosphamide.

- Coverage may be approved for a maximum of 375 mg per square metre of body surface area weekly for 4 weeks.- Patients will be limited to receiving two doses of rituximab per prescription at their pharmacy. - For relapse following a remission, coverage may be provided for patients who experience a flare of severe active disease that is life- or organ-threatening; or, who experience worsening symptoms in 2 or more organs even if not life-threatening. Note: For relapse following a rituximab-induced remission, additional coverage may be approved no sooner than 6 months after previous rituximab treatment."

All requests (including renewal requests) for Rituxan for Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) must be completed using the Rituxan for Granulomatosis with Polyangiitis/Microscopic Polyangiitis Special Authorization Request Form (ABC 60018).



at least FOUR of the following, where at least one of which must be a minimum 12-week trial of an anti-tumor necrosis factor therapy- Actemra (tocilizumab)- Brenzys (etanercept)- Cimzia (certolizumab pegol)- Erelzi (etanercept)- Inflectra (infliximab)- Kevzara (sarilumab)- Orencia (abatacept)- Renflexis (infliximab)- Simponi (golimumab)- Xeljanz (tofacitinib)

AND

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinicalresponse to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND- Methotrexate with other disease modifying anti-rheumatic agent(s) (minimum 4 month trial). [e.g., methotrexate with hydroxychloroquine or methotrexate with sulfasalazine]; AND- Leflunomide (minimum 10 week trial at 20 mg daily).

'Refractory' is defined as lack of effect at the recommended doses and for duration of treatments



RITUXIMAB

10 MG / ML INJECTION

00002241927 RITUXAN HLR 48.2308


$

.3

specified above.'Intolerant' is defined as demonstrating serious adverse effects or contraindications totreatments as defined in product monographs.


- Initial coverage may be approved for a dose of 1000 mg of rituximab administered at 0 and 2 weeks (total of 2 - 1000 mg doses).- Patients will be limited to receiving one dose of rituximab per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients will not be permitted to switch from anakinra to other biologic agents except under exceptional circumstances.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For coverage for an additional two-dose course of therapy, the patient must meet the following criteria:1) The patient must be assessed by an RA Specialist after each course of therapy, between 16 and 24 weeks after receiving the initial dose of each course of therapy, to determine response.2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the following criteria:- An improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place] following the initial course of rituximab; AND- An improvement of 0.22 in HAQ score [reported to two (2) decimal places] following the initial course of rituximab.It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the correct number of decimal places as indicated above, AND3) The patient must have residual disease or disease activity returning to a level above a DAS28score of 2.6.

Subsequent courses of therapy cannot be considered prior to 24 weeks elapsing from the initial dose of the previous course of therapy."

All requests (including renewal requests) for rituximab for Rheumatoid Arthritis must be completed using the Rituximab for Rheumatoid Arthritis Special Authorization Request Form (ABC 60046).




USTEKINUMAB


Plaque Psoriasis

"Special authorization coverage may be provided for the reduction in signs and symptoms of severe, debilitating plaque psoriasis in patients who:- Have a total PASI of 10 or more and a DLQI of more than 10, OR- Who have significant involvement of the face, palms of the hands, soles of the feet or genital region; AND- Who are refractory to or intolerant to:at least TWO of the following:- Cosentyx (secukinumab)- Inflectra (infliximab)- Renflexis (infliximab)- Taltz (ixekizumab)

AND

- Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory, OR- Cyclosporine (6 weeks treatment); AND- Phototherapy (unless restricted by geographic location)

Patients who have a contraindication to either cyclosporine or methotrexate will be required to complete an adequate trial of the other pre-requisite medication prior to potential coverage beingconsidered.



- Initial coverage may be approved for three doses of 45 mg (90 mg for patients weighing greater than 100 kg) at weeks 0, 4 and 16.- Patients will be limited to receiving one dose per prescription at their pharmacy.- Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period).- Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy.- Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage, the patient must meet all of the following criteria:1) The patient must be assessed by a Dermatology Specialist after the initial 16 weeks of therapy to determine response.2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:- Greater than or equal to 75% reduction in PASI score, OR- Greater than or equal to 50% reduction in PASI score AND improvement of greater than or equal to 5 points in the DLQI.

Following this assessment, continued coverage may be considered for 45 mg (90 mg for patients weighing greater than 100 kg) every 12 weeks for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in



USTEKINUMAB

45 MG INJECTION VIAL OR SYRINGE

90 MG / SYR INJECTION SYRINGE

00002320673

00002320681

STELARA (0.5 ML VIAL OR SYRINGE)

STELARA (1.0 ML SYRINGE)

JAI

JAI

4465.5800

4465.5800


For this product - pricing has been established on a per vial or syringe basis.$

$

.3

(2) above."


All requests (including renewal requests) for ustekinumab for Plaque Psoriasis must be completed using the Adalimumab/Etanercept/Infliximab/Ixekizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030).


updates to the alberta drug benefit list · for coverage, this drug must be initiated by a...

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